View clinical trials related to Mitral Valve Insufficiency.
Filter by:The MitraClip-procedure offers an interventional treatment for high risk patients with severe symptomatic mitral regurgitation. The number of new cerebral ischemic lesions without clinical manifestations is high. The aim of this study is to determine the frequency of cerebral embolisms and cerebral lesions during the MitraClip-procedure using transcranial doppler ultrasound and magnetic resonance imaging.
The Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Mitral Regurgitation. The device system is to be used only in accordance with the approved Investigational Plan on subjects who have signed an informed consent form. Device use is limited to the approved study investigators.
Serum-creatinine level (s-Cr) is an important factor for predicting perioperative patient's outcome regarding acute kidney injury. Although cardiopulmonary bypass (CPB), an essential procedure for cardiac surgery, dilutes patient's blood components, possible impact of applying acute normovolemic hemodilution (ANH) and CPB on s-Cr has not been well investigated. In patients undergoing cardiac surgery employing moderate hypothermic CPB (age 20-71 years, n=32), ANH will be randomly applied to 15 patients (Group-ANH) but not in 17 patients (Group-C) before initiating CPB. For ANH procedure consisting of 5 ml/kg of blood salvage and administering 5 ml/kg of balanced hydroxyethyl starch (HES) 130/0.4 for 15 min will be started at 30 min after anesthesia induction and before CPB application for surgery. In both groups, moderate hypothermic CPB will be initiated by using 1600-1800 ml of bloodless priming solution. The changes of hematocrit (Hct), Na+, K+, HCO3-, Ca2+, osmolarity, s-Cr will be determined before ANH (T1), after the first ANH of 2.5 ml/kg (T2), and after the second ANH of 2.5 ml/kg (T3), 30 sec and 60 sec after the initiation of CPB (T4, T5), immediately and 1 hour after the weaning from CPB (T6, T7) and at the end of surgery (T8). S-Cr will be determined by using a point-of-care test device (StatSensor™ Creatinine, Nova Biomedical, USA).
The purpose of this study is to evaluate the safety and performance of the Harpoon Medical TSD-5. The Harpoon device will provide many significant advantages over current surgical interventions including: 1) a small minimally invasive incision, 2) no sternotomy, 3) no cardiopulmonary bypass, 4) no aortic manipulation, 5) a direct path to the valve plane, 6) performed on a beating heart, 7) real-time TEE-guided chordal length adjustment and 8) less complicated procedure that is teachable and adoptable.
The purpose of this study is to evaluate the safety and performance of the Harpoon Medical device. It is anticipated, that the Harpoon Medical device will provide advantages over current surgical interventions including: 1) a small minimally invasive incision, 2) no sternotomy, 3) no cardiopulmonary bypass, 4) no aortic manipulation, 5) a direct path to the valve plane, 6) performed on a beating heart, 7) real-time TOE-guided chordal length adjustment and 8) less complicated procedure that is teachable and adoptable.
The purpose of this study is to determine the prevalence of moderate-to-severe Mitral Regurgitation (MR) in acute Heart Failure (HF) patients requiring hospital admission.
Functional MR is caused by adverse left ventricular remodeling after myocardial injury and associated with an increased incidence of heart failure and death. Because secondary functional MR usually develops as a result of LV dysfunction, diuretics, beta blockers, angiotensin-converting-enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB), and aldosterone antagonists are given to patients with functional MR in line with the guidelines in the management of heart failure. However, functional MR appears to remain common despite use of these drugs and current medical treatment is usually insufficient for reducing MR or reversing the adverse LV remodeling. As LCZ696 is a dual-acting inhibitor of the renin-angiotensin-aldosterone system (RAAS) and neutral endopeptidase (NEP), LCZ696 has greater hemodynamic and neurohormonal effects than ARB alone. Investigators try to examine the hypothesis that LCZ696 is superior to ARB alone in improving functional MR in patients with LV dysfunction and functional MR.
Multi center evaluation of the Millipede IRIS for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.
The main objective of this project is to determine intermediate-term echocardiographic outcomes in Medicare eligible patients (65 years of age and older) with moderate surgical risk who have undergone mitral valve surgery for degenerative mitral regurgitation.
A multi center study to evaluate the safety of the AMENDTM Mitral Valve Repair System and its ability to reduce mitral regurgitation. AMEND device is an annuloplasty ring implanted in a minimally invasive trans-catheter method.